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Grand Jury Convened to Look into Criminal Charges Against Boston Scientific Over Counterfeit Mesh

Polypropylene raw resin pellets

Polypropylene raw resin pellets

Mesh Medical Device News Desk, April 14 2016 ~ The Boston Globe reports a grand jury will determine if criminal charges should be filed against Boston Scientific (BSC) for using counterfeit raw material from China to make its vaginal mesh implant.

A grand jury in Charleston, W.V. will determine whether BSC engaged in deceptive trade practices by knowingly receiving substandard polypropylene resin from China and then sold that defective product to women and their doctors.

Multiple subpoenas have been sent out, reports the Globe, though a Boston Scientific spokeswoman says the company has not received one.

In a February 24 regulatory filing, BSC said the US attorney’s office in West Virginia was looking into the allegations of defective mesh resin.  bs logo

The Houston-based Mostyn law firm in January accused the company of running an international conspiracy to sell defective mesh.  The Marlborough, Massachusetts-based BSC denies that.

The lawsuit seeks class-action status on behalf of about 55,000 women who have received the pelvic mesh implants since September 2012, the date after which the Chinese-sourced polypropylene resin would have been used. The case is Teresa Stevens. V. Boston Scientific Case no. 2:16-cv-00265).

BSC is working to test its pelvic mesh implants crafted allegedly from the Chinese-sourced mesh to see if it contains high levels of selenium, a trace element that can be toxic at high levels. The firm had a Boston polymer lab test the raw resin and found it contained high levels of selenium. “As a rare and toxic element, this result is unusual and should be verified by using another technique, such as SEM-EDS,” said the report.

The Food and Drug Administration acknowledged the allegations filed in the RICO action but did not recommend that women have their mesh implants removed.

Mostyn law said when BSC lost its US supplier of raw polypropylene, it turned to a known counterfeiter in China. Mostyn says the company acted like a drug dealer then to hide 37,000 pounds of the substandard resin from customs agents in the U.S. and China.

Yesterday in a letter to the FDA and Health and Human Services, Amber Mostyn urged the FDA to pursue criminal charges with the Department of Justice and not just compare old pelvic mesh implants to new ones.

Amber Anderson Mostyn

Amber Anderson Mostyn

“The FDA‘s investigation should not be into the quality of the raw material, but rather the source of the raw material. Allowing the defense of equivalence undermines the public policy positions articulated in the very statutes Congress passed to prevent this type of criminal conduct.”~Amber Mostyn

Criminal penalties for smuggling counterfeit material and endangering public health can range from 20 years in prison for serious bodily harm to life in prison for death and a $15 million corporate fine.

The law firm points to documentation that was lacking in the imported material or sourced the material from two different Chinese suppliers. The low-cost material, lower than market value, was split into separate shipments and sent to different ports.

Boston Scientific reports net sales for its urology and pelvic health products were $693 million at the end of 2015, an increase of 30 percent over the prior year.

The company is facing almost 21,000 product liability lawsuits filed in multidistrict litigation, one of seven mesh manufacturers consolidated in one federal court in Charleston, WV.

 

LEARN MORE:

Boston Globe, April 13, 2016, Grand jury convened in probe of Boston Scientific
https://www.bostonglobe.com/business/2016/04/13/grand-jury-convened-probe-boston-scientific/v00hHy7djMd3xJfAH5f37J/story.html

BSC Form 10-K
http://www.sec.gov/Archives/edgar/data/885725/000088572516000028/a2015form10-k.htm

April 12, Letter to FDA
STEVENS FINAL LETTER TO FDA (1)

Prosecuting Intellectual Property Crimes (here)

FDA Notice, April 1, 2016
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm493784.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mostyn Law Court Documents, Citizen Petition
https://vaginalmeshclassaction.com/exhibits/

Mesh News Desk, Jan. 15, 2016 – RICO Suit Accused Boston Scientific of Fraud in Smuggling Defective Pelvic Mesh from China
http://www.meshmedicaldevicenewsdesk.com/class-action-lawsuit-accuses-boston-scientific-of-obtaining-defective-mesh-from-china/

RICO Complaint Jan 12, 2016
https://s3.amazonaws.com/static.mostynlaw.com/wp-content/uploads/sites/4/2016/01/RICO-Complaint.pdf

24 Comments

  1. Connie says:

    Wow this is a wonderful step toward those that didn’t care to harm & potentially kill thousands !! As God is my witness His children including me we rise up and call The Lord blessed for ultimately taking care of innocent people . When we thought no one cared He had His eyes on us .God was here all the time & I wash the blood of those that harmed us from my hands and heart for vengeance is mine sayth the Lord !!!

    • Mary Pat says:

      Connie, I say Amen and praise the Lord. Try as I might to come up with ideas to bring ghis ugly truth to light and to obtain justice for all, my personal efforts don’t seem to accomplish much. I keep believing with absolute faith that God will avenge His children. We see Him working on our behalf.

  2. bob sandoval says:

    How do we know if the other manufactures didn’t get their supplies of mesh resin from China also? Doesn’t that make you think if one wants to make more $ than the other.

    • Jane Akre says:

      IT certainly raises questions…. the resin suppliers wanted to be indemnified, ie shielded from any liability when they found out the resin was going to implantable medical devices…..you might recall Bard formed a dummy company so its supplier wouldnt discover their resin was going to pelvic mesh.

      • Shirley D says:

        Might be why Important Documents that would of proved this theory were destroyed by J&J and Ethicon. They got rid of evidence that would be very valuable in all our cases. They don`t care nor do our attorneys how much we suffer its all about the almighty dollar and then when you ask questions about your case the para-legal says seems like your after money. I am after money I say I am injured I am after Justice several years of suffering no amont of money is going to compensate what I have lost and cannot ever get back one thing is my woman hood…Pain and suffering is just part of it considering I cannot have a normal relationship with a man.

        • Jo says:

          The pain and suffering is way past the idiot manufactures statements. The main issue with the problems and confusion besides the illegal resin made mesh from China is that the ladies that take the stand in court are not speaking out what needs to be heard.
          I’ve had predentail injections biweekly for years. I knw they have too. They need to let the court knw how it’s done and how painful it is. I have had 3 surgeries since my explant. Injecting the nerves with botox. It helps only for 9 months tops, and is expensive to get this surgery. Then back to the painfull predentail injections until a year is exhausted, before another botox nerve block surgery is given again. I still have pieces of the mesh in my pelvic organs today. I don’t knw if the court-judge know if this horrific pain and the change of our lives we have will be forever. Have all you ladies asked yourself this? When does this pain and hospital bills go away? Who pays for the medical bill, surgeries after the little settlements are awarded? I know I have problems with my sexual relationship right now.

        • Jo says:

          Besides the illegal mesh, the worst problem and issues still awaits us all. I have had 4 surgeries since the product failed in my body. I still have mesh pieces in my vaginal walls. My sexual relationship is missing in my life. Botox nerve block surgeries are expensive. When does the pain leave our pelvic organs? Will we ever be the same person? Who pays the medical bills after the little settlements are awarded? The injured ladies In The courtroom need to speak up! They need to tell the court how injections and surgeries are done and explain the pain of the procedures. They need to be thorough.

  3. Linda says:

    It is beyond my ability to comprehend the depths of discovery of all the dangers of any mesh product used in a human body. How do some sleep at night? Why are so many greedy? How can so many not care for their human race?

  4. lily says:

    Is so hard to believe that they would do something so terrible to humans just to make money when they always rake in millions everyday, they will have to pay for being so heartless, so sad for every one that is so sick,I would love to go back before I had the poison put in me,God bless, Lily

  5. just me says:

    My sticker page identified my mesh as being manufactured in China. I was implanted with Boston scientific obtsling sling in 2007.

  6. just me says:

    Obtryx

    • Disgusted says:

      Are you kidding me? Where was this info.? I had the obtryx in the end of 2007. I have not found this. Could there have been more than one supplier?

      • Jane Akre says:

        This information was contained in the discovery law firms got from Boston Scientific. Apparently this firm in Houston was the one that read carefully the documents and decided to act on it. Don’t know about the others. If you have Boston Sci mesh after 2011, is your law firm looking into whether or not it was made with counterfeit mesh? It may be one more count to add to your complaint is my understanding but I’m not a lawyer. Check with your law firm on that. The evidence is solid.

  7. Linda says:

    I started reading the side effects of high levels of Selenium and low and behold
    Hair loss, weight loss, nail problems, nerve damage and difficulty walking. The list goes on and on. I found a study they did on deer and they develop lameness , symptoms that look like wasting disease.

    • Jane Akre says:

      Interesting. This would likely be in meshes they made after they imported the chinese resin…. 2011 or 2012/…

  8. Disgusted says:

    I hope the truth comes out. This is the first part of a long journey. Wording and body language matter. I believe it has become more political then factual. Of course, it may have always been that way. How do they figure out who to hold accountable?

  9. Karen says:

    Women With Vaginal Mesh Complications Have Increased Levels of Inflammation Around Implant: Study

    Amid tens of thousands of vaginal mesh lawsuits filed by women throughout the U.S. who have experienced problems following surgical repair of pelvic organ prolapse or female stress urinary incontinence, a new study indicates that women who experienced problems with pelvic mesh were more likely to have inflammation around the implant.

    In a study published this week in the American Journal of Obstetrics & Gynecology, researchers with the Magee-Womens Research Institute in Pittsburgh set out to evaluate reactions among patients undergoing vaginal mesh excision surgery after experiencing complications.

    Researchers found that inflammation and concentrations of white blood cells designed to attack foreign material were more commonly found among in women who suffered vaginal mesh complications like extrusion of the mesh through the vagina and other problems than those who simply reported pelvic pain.

    In July 2011, the FDA warned that it had received thousands of adverse event reports involving problems with vaginal mesh products between January 2008 and December 2010. This led to an influx of product liability lawsuits against manufacturers of the devices, with about 100,000 women nationwide presenting claims for injuries and complications allegedly caused by the defective design of the mesh.

    Following a review of all available data, the FDA concluded that there was no evidence that transvaginal mesh provides any additional benefits when compared to more traditional surgery for treatment of pelvic organ prolapse, and manufacturers of the devices have been ordered to conduct studies to evaluate the safety.

    Although the risk of complications from vaginal mesh have been a hot topic within the medical community for several years, researchers in this latest study note that few studies have been performed that focus on how women’s bodies respond to synthetic surgical mesh used for pelvic organ prolapse and stress urinary incontinence.

    Researchers looked at 27 mesh-vaginal tissue samples from women who suffered complications and found that macrophages surrounded the implants. They found women who required mesh removal due to exposure, such as when the mesh penetrates the wall of the vagina, had 88.4% higher concentrations of macrophages than those explanted for pain.

    “In women with complications, mesh induces a pro-inflammatory response that persists years after implantation, the researchers found. They also determined that the types of white blood cells found in mesh explanted for exposure were associated with degradation, while the types around those removed for pain were more indicative of fibrosis.

    Several manufacturers of transvaginal mesh and bladder sling products have agreed to pay several billion in vaginal mesh settlements for women who have experienced problems, and thousands of cases are continuing to move forward through the court system. The transvaginal mesh litigation has been the largest mass tort in the United States over the past decade.

    – See more at: http://www.aboutlawsuits.com/vaginal-mesh-complications-study-99141/#sthash.uZ9ULE2B.dpuf

    • Still Standing says:

      Karen, do you kmow the title/authors of this study. I have tried to find it in the April2016 journal table of contents and I can’t seem to find it there. It could have been a poster presentation at a convention as opposed to a journal article, which could change the interpretation of the results somewhat. Just have not been able to read the article or abstract. Let me know if you have access to that information.

  10. Destrey says:

    Thanks guys, I just about lost it looking for this.

  11. Sea says:

    Wish I NEVER allowed my doctor to put this BS mesh mess inside me ….doing everything I know today to live …

  12. Still Standing says:

    Here is the full abstract of the study referenced above. The website it was pulled from did not interpret the results appropriately, nor did they reference the study’s investigators nor cite the American Journal of Obstetrics and Gynecology, where the article appears. As a researcher myself, no one should use the intellectual property of others without citing it correctly. That said, the interpretation looked as if women with mesh who had excision for pain and not erosion were not impacted. It also failed to mention the 30 women who did not have mesh but were having some other gynecological surgery. That is the control group. The 27 women with mesh,15 for SUI and 12 for prolapse are the research focus. It is important to understand this because the mesh tissue samples were compared to a control group. The conclusion on the legal website that only women with mesh erosion had inflammatory cell responses is not accurate. The women who had mesh surgery for only pain DID show significant differences from the control group. The pain only group also had an inflammatory response, but with different types of cells, ones that encapsulte the mesh instead of trying to disintegrate the mesh. To me, this shows how women who have pain with no erosion also have inflammatory responses and continued damage from the mesh. It is significant because the settlements seem to be based on how many surgeries a woman has for erosion and other tangible complications. As studies go,it was very small,but hopefully it will lead other researchers to look at this aspect of women with mesh who do not have erosion. This may have confused you, but read the abstract below and if you have questions about the findings, I will be glad to answer Your questions. I imagine I will not have the answers to quite a few questions, especially medical ones, but I can help interpret the results if you want to know more. Here is the full abstract ( an abstract is just a short version of the study).

    Background

    In spite of good anatomical and functional outcomes, urogynecologic polypropylene meshes used to treat pelvic organ prolapse and stress urinary incontinence are associated with significant complications, most commonly mesh exposure and pain. Few studies have been performed that specifically focus on the host response to urogynecologic meshes. The macrophage has long been known to be the key cell type mediating the foreign body response.

    Conceptually, macrophages responding to a foreign body can be broadly dichotomized into M1 pro-inflammatory and M2 pro-remodeling subtypes. A prolonged M1 response is thought to result in chronic inflammation and the formation of foreign body giant cells with potential for ongoing tissue damage and destruction. While a limited M2 predominant response is favorable for tissue integration and ingrowth, excessive M2 activity can lead to accelerated fibrillar matrix deposition, resulting in fibrosis and encapsulation of the mesh.

    Objectives

    To define and compare the macrophage response in patients undergoing a mesh excision surgery for the indication of pain versus a mesh exposure.

    Study design

    Patients scheduled to undergo a surgical excision of mesh for pain or exposure at Magee-Womens Hospital were offered enrollment. Twenty-seven mesh-vagina complexes removed for the primary complaint of a mesh exposure (N=15) vs pain in the absence of an exposure (n=12) were compared to 30 full thickness vaginal biopsies from women undergoing benign gynecologic surgery without mesh. Macrophage M1 pro-inflammatory versus M2 pro-remodeling phenotypes were examined via immunofluorescent labeling for cell surface markers CD86 (M1) vs CD206 (M2) and M1 vs M2 cytokines via enzyme-linked immunosorbent assay (ELISA). The amount of matrix metalloproteinase-2 (MMP-2) and matrix metalloproteinase-9 (MMP-9) proteolytic enzymes were quantified by zymography and substrate degradation assays, as an indication of tissue matrix degradation. Statistics were performed using one-way ANOVA with appropriate post hoc tests, t-tests, and Fisher’s Exact test.

    Results

    Twenty-seven mesh-vaginal tissue complexes were excised from 27 different women with mesh complications – 15 incontinence midurethral slings and 12 prolapse meshes. Upon histological examination, macrophages surrounded each mesh fiber in both groups, with predominance of the M1 subtype. M1 and M2 cytokines/chemokines, MMP-9 (pro and active), and MMP-2 (active) were significantly increased in mesh-vagina explants as compared to vagina without mesh. Mesh explants removed for exposure had 88.4% higher pro-MMP-9 (p=0.035) than those removed for pain. A positive correlation was observed between the profibrotic cytokine IL-10 and the percentage of M2 cells (r=0.697, p=0.037) in the pain group.
    Conclusion

    In women with complications, mesh induces a pro-inflammatory response that persists years after implantation. The increase in MMP-9 in mesh explants removed for exposure indicates degradation while the positive association between IL-10 and M2 macrophages in mesh explants removed for pain is consistent with fibrosis.
    Host Response to Synthetic Mesh in Women with Mesh ComplicationsOriginal Research Article
    American Journal of Obstetrics and Gynecology, In Press, Accepted Manuscript, Available online 16 April 2016
    Alexis L. Nolfi, Bryan N. Brown, Rui Liang, Stacy L. Palcsey, Michael J. Bonidie, Steven D. Abramowitch, Pamela A. Moalli

  13. elizabeth s says:

    my mesh was in planted in 2010 Boston S. Ever since I have had autoimmune problems. And I mean everything…….
    Has anyone had problems like this?
    PS. Going to Dr. Hibner in Phx. AZ
    I hope he can get it all. Then maybe my body will stop attacking me.
    If my mesh was put in , in 2010 would that have been the bad lot from China? I cant even work anymore, im a mess.

    Thanks for listening.

    • Jane Akre says:

      Please fill out the autoimmune registry… on page one of Mesh News Desk. Researchers will be taking the information to further study autoimmune issues. I will be announcing it soon. Thanks

  14. Elreana says:

    Thanks for the information I just read..I thought I was the only one who was going through this BS ..No sex life, can’t work,had to have it removed because of infection in my cervix and ureus area which had to be removed ,back problems, now bladder infection always,hip problems,can’t walk,now I am walking with a cane . and you said they only paying a little money.

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